510(k) K071971

DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL by Diazyme Laboratories — Product Code LPS

K071971 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL". The FDA issued a decision of Substantially Equivalent on September 17, 2007. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Diazyme Laboratories has at least 10 other 510(k) clearances on record.